Italian Multicenter Database for Open Conversions After EVAR

Not yet recruiting

• Conditions: Abdominal Aortic Aneurysm Enlargement; Abdominal Aortic Aneurysm
• Interventions: Procedure: Open Conversion after EVAR; Procedure: SemiConversion after EVAR

• Registration Number: NCT04299984
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

Brief Summary

Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).

LOC is defined as a total or partial endograft explantation \>30 days after the initial EVAR.

SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.

The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09
• Study Start: 2020-08-01
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• open or laparoscopic surgery for EVAR complications, with or without endograft explantation

Exclusion Criteria

• endovascular reinterventions
• extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Conversions	Open Conversion after EVAR	Patients undergoing total or partial endograft explantation for any EVAR complication.
SemiConversions	SemiConversion after EVAR	Patients undergoing open or laparoscopic surgery for any EVAR complication (mostly endoleak correction) with complete endograft preservation.

Primary Outcome Measures

Name	Time	Method
Early Mortality	30 days	30-day mortality after surgery
In-hospital Mortality	90 days	Mortality during in-hospital stay
Long-term survival	4 years	Long-term survival rate

Secondary Outcome Measures

Name	Time	Method
Related complications	4 years	Aorta-related complications during follow-up
Early Morbidity	30 days	Major complications after surgery